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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K110948
Device Name HEALTH CARE SYSTEM SOFTWARE
Applicant
TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
NEW TAIPEI COUNTY,  TW 24888
Applicant Contact TELING HSU
Correspondent
TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
NEW TAIPEI COUNTY,  TW 24888
Correspondent Contact TELING HSU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
DXN   FLL  
Date Received04/04/2011
Decision Date 05/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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